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EP3461843A3 - Anti-cd19 antibody having adcc and cdc functions and improved glycosylation profile - Google Patents

Anti-cd19 antibody having adcc and cdc functions and improved glycosylation profile Download PDF

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Publication number
EP3461843A3
EP3461843A3 EP18192521.5A EP18192521A EP3461843A3 EP 3461843 A3 EP3461843 A3 EP 3461843A3 EP 18192521 A EP18192521 A EP 18192521A EP 3461843 A3 EP3461843 A3 EP 3461843A3
Authority
EP
European Patent Office
Prior art keywords
relates
antibody
antibodies
region
present
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP18192521.5A
Other languages
German (de)
French (fr)
Other versions
EP3461843B1 (en
EP3461843A2 (en
Inventor
Claudine Vermot-Desroches
Boris Sebastien Vuillermoz
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International Drug Development Biotech SAS
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International Drug Development Biotech SAS
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Publication of EP3461843A2 publication Critical patent/EP3461843A2/en
Publication of EP3461843A3 publication Critical patent/EP3461843A3/en
Application granted granted Critical
Publication of EP3461843B1 publication Critical patent/EP3461843B1/en
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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3061—Blood cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/524—CH2 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/526—CH3 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/72—Increased effector function due to an Fc-modification
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/734—Complement-dependent cytotoxicity [CDC]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/77—Internalization into the cell

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Cell Biology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Transplantation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Saccharide Compounds (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

The present invention relates to an anti-CD19 antibody having a variant Fc region having some specific amino acid modifications relative to a wild-type Fc region which confer one or several useful effector functions. The present invention relates in particular to chimeric, humanized or full human anti-CD19 antibodies comprising such a variant Fc region. It relates advantageously to antibodies with an interesting and valuable glycosylation profile, especially a low fucose level and/or a high oligomannose level and low level of sialylated glycoform. The present invention also relates to the use of these antibodies in the treatment, prevention or management of disease or disorder, such as cancer, especially a B-cell malignancy, and auto-immune disease.
EP18192521.5A 2010-07-19 2011-07-18 Anti-cd19 antibody having adcc and cdc functions and improved glycosylation profile Active EP3461843B1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US36554810P 2010-07-19 2010-07-19
EP10305796A EP2409712A1 (en) 2010-07-19 2010-07-19 Anti-CD19 antibody having ADCC and CDC functions and improved glycosylation profile
PCT/EP2011/062271 WO2012010562A1 (en) 2010-07-19 2011-07-18 Anti-cd19 antibody having adcc and cdc functions and improved glycosylation profile
EP11732491.3A EP2595662B1 (en) 2010-07-19 2011-07-18 Anti-cd19 antibody having adcc and cdc functions and improved glycosylation profile

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
EP11732491.3A Division EP2595662B1 (en) 2010-07-19 2011-07-18 Anti-cd19 antibody having adcc and cdc functions and improved glycosylation profile

Publications (3)

Publication Number Publication Date
EP3461843A2 EP3461843A2 (en) 2019-04-03
EP3461843A3 true EP3461843A3 (en) 2019-04-24
EP3461843B1 EP3461843B1 (en) 2023-09-06

Family

ID=43425912

Family Applications (3)

Application Number Title Priority Date Filing Date
EP10305796A Withdrawn EP2409712A1 (en) 2010-07-19 2010-07-19 Anti-CD19 antibody having ADCC and CDC functions and improved glycosylation profile
EP11732491.3A Active EP2595662B1 (en) 2010-07-19 2011-07-18 Anti-cd19 antibody having adcc and cdc functions and improved glycosylation profile
EP18192521.5A Active EP3461843B1 (en) 2010-07-19 2011-07-18 Anti-cd19 antibody having adcc and cdc functions and improved glycosylation profile

Family Applications Before (2)

Application Number Title Priority Date Filing Date
EP10305796A Withdrawn EP2409712A1 (en) 2010-07-19 2010-07-19 Anti-CD19 antibody having ADCC and CDC functions and improved glycosylation profile
EP11732491.3A Active EP2595662B1 (en) 2010-07-19 2011-07-18 Anti-cd19 antibody having adcc and cdc functions and improved glycosylation profile

Country Status (11)

Country Link
US (2) US9663583B2 (en)
EP (3) EP2409712A1 (en)
JP (2) JP6092102B2 (en)
CN (2) CN105111312B (en)
CA (1) CA2805994C (en)
DK (1) DK2595662T3 (en)
ES (1) ES2700294T3 (en)
IN (1) IN2013CN01338A (en)
PL (1) PL2595662T3 (en)
PT (1) PT2595662T (en)
WO (1) WO2012010562A1 (en)

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EP2409712A1 (en) * 2010-07-19 2012-01-25 International-Drug-Development-Biotech Anti-CD19 antibody having ADCC and CDC functions and improved glycosylation profile
CN102636655B (en) * 2012-05-10 2014-07-23 苏州大学附属第一医院 Fluorescence in-situ micro-lymphocytotoxicity detection method and kit
KR20170003720A (en) * 2014-05-27 2017-01-09 아카데미아 시니카 Anti-cd20 glycoantibodies and uses thereof
EP3166972B1 (en) * 2014-07-08 2020-03-11 TDW Group Antibodies to argininosuccinate synthase and related methods
FR3024453B1 (en) * 2014-08-01 2018-06-29 Lab Francais Du Fractionnement PROCESS FOR PRODUCING VARIANTS HAVING FC HAVING ENHANCED SIALYLATION
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US10617691B2 (en) 2015-05-26 2020-04-14 Morphosys Ag Combination of an anti-CD19 antibody and a Bruton's tyrosine kinase inhibitor and uses thereof
US10493139B2 (en) 2015-07-24 2019-12-03 Innovative Cellular Therapeutics CO., LTD. Humanized anti-CD19 antibody and use thereof with chimeric antigen receptor
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CN115702164A (en) * 2020-04-17 2023-02-14 詹森生物科技公司 Biosynthetic glycoprotein populations
EP3915641A1 (en) * 2020-05-27 2021-12-01 International-Drug-Development-Biotech Anti-cd5 antibodies and methods of use thereof
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